Medical Device Prototype Stent from China
Drug-eluting coronary stent prototype with experimental polymer coating for benchtop and animal model testing. Imported by medical device company for regulatory submission fatigue testing. 9813.00.30 for experimental medical device development.
Duty Rate — China → United States
12.5%
Rate breakdown
9903.05.3112.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of China, as provided for in U.S. note 52 to this subchapter
Import Tips
• FDA IDE number and test protocol mandatory for clearance
• Include animal study approvals and destruction plans
• Small quantities only - production lots trigger Chapter 90 classification